Once given FDA approval, the Senseonics Eversence System will be the fourth CGMS available in the U.S. It was submitted to the FDA for premarket approval last October, supported by data from a 90-patient pivotal trial of the device. The trial followed adults with type 1 or type 2 diabetes over 90 days of CGM sensor wearing. This is an implantable CGM system that is currently approved in Europe. The sensor sits just under your skin and can stay there for anywhere from 90-180 days (recently approved for 180 days in Europe). You have to place a transmitter on your arm over the implanted sensor, which is a fairly flat black ergonomic device with adhesive on the back. It’s probably the size of two quarters put together but rounded and smooth. This transmitter powers the implanted sensor and also sends the CGM information to an app on your phone. After insertion there is about a 24-hour one-time “warm up” period. Then you can start entering calibrations (twice a day) and you’re off and running until you get a new sensor placed.
Based on innovative fluorescence technology embedded within a tiny sensor, the Eversense CGM System measures glucose from interstitial fluid below the skin surface. The sensor wirelessly sends glucose data to the smart transmitter worn on the upper arm over the sensor insertion site. The smart transmitter calculates the current glucose value along with the direction it’s headed, how fast, and whether glucose values are expected to exceed pre-set low and high targets. Data and alerts are simultaneously sent to the smartphone app that provides real-time tracking, intuitive displays to help identify patterns, and information to help stay in range.
The Eversense app runs on a compatible mobile device to receive and display the sensor glucose data from the Eversense Smart Transmitter. It provides easy access to real-time glucose measurements and eliminates the need to carry a separate receiver device. In addition to seeing your current glucose value every 5 minutes, the app also displays where your glucose is headed and how fast, so you can take action confidently.
Dr. Steven Edelman, while attending the ESAD meeting, tried the device to get his thoughts. Dr. Edelman came away with some pros and cons and shared them in the TCOYD.com newsletter for this month.
- It’s super nice not to have to put on a new transmitter every week or so, or worry about being out without one.
- I haven’t had to worry about a “bad” sensor, or getting question marks, or worry about the sensor falling off or coming out.
- I like that I can take off the transmitter whenever I want and have nothing attached to me at all. When I put it back on, it starts reading again right away. You can’t really temporarily take off our currently available CGMs. It’s very accurate with MARD (measure of accuracy) that is in the 8% range, which would make it at least as accurate, if not more so, than currently available CGMs
- Predictive high and low alerts are an option and can be set to alarm when you are going to go high or low in the next 10, 20, or 30 minutes.
- The Eversense has cloud sharing capabilities.
- You have to charge the transmitter every day, which takes about 10 minutes. The charge does last ~42 hours in case you forget. I do it while taking a shower. Steve says that if you are French, you will have to figure out a different time of day as a reminder system. If the transmitter battery runs out of juice, your readings will be interrupted until you charge it.
- The charger for the transmitter is unique to the device, so if you lose it you can’t just go out and buy one (not like losing an iPhone charger). So hopefully you can get an extra one when the device is approved.
- The interface on the app needs to be more user friendly. It does give you reports, but they aren’t as slick as others we are used to, and it takes a while to find the data you want. Other things are a little strange. For example, you have to enter times when you “eat a snack.” The procedure, while not a big deal, is still a procedure and something you would have to schedule every 90 to 180 days.
- The Eversense will initially be approved for 90 days, but the company will quickly apply to the FDA for the 180-day approval.
Dr. Edelman’s final thoughts include that it definitely has its pluses and minuses; he adds, “My hope is that this will be an attractive option to some folks and expand the number of type 1s we have using CGMs, which is sadly still pretty low (only about 20%!).”